11 Mar Third Wave's HPV clinical trial hits key goals
Madison, Wis. – Third Wave Technologies, a Madison-based developer of molecular diagnostic products, has achieved its primary goals in the clinical trial for its human papillomavirus (HPV) tests, and expects to submit the trial results to the U.S. Food and Drug Administration for both its high-risk and 16/18 genotyping products in April, the company announced.
The company’s high-risk HPV test is intended to be used in combination with a Pap test to assess women 30 and over for the presence of high-risk HPV types, and to guide their treatment. It is also designed to test patients with abnormal Pap results to determine whether they should be referred to colposcopy.
Third Wave also has achieved the primary clinical objectives for its HPV genotyping test, which detects the presence of HPV types 16 and 18 – the types that cause approximately 70 percent of cervical disease.
The company, which initiated its HPV clinical trial in early 2006, has screened more than 50,000 subjects and enrolled over 3,400 subjects from 47 sites, including more than 1,300 women with Pap test results.
Third Wave plans to enter the global market for HPV testing, which is projected to be $250 million in 2008. The company said the U.S. market alone is approximately $200 million annually, has grown in excess of 40 percent for each of the last five years, and market growth is expected to continue in excess of 25 percent in the near future.
Kevin Conroy, president and chief executive of Third Wave, said the clinical trial results validate the company’s investment in the HPV program.
“The clinical utility of HPV testing is well documented, and we look for the market to continue to grow and further penetrate clinical practice in the United States and internationally,” Conroy said in a statement released by the company.
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